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01 Nov 2019

CLH Blog - MHRA Field Safety Updates For October 2019

CLH Blog - MHRA Field Safety Updates For October 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Phillips - Professional use defibrillator/monitor: Efficia DFM100 - Field Safety Alert

(Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039). Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

Action: 

Identify affected devices in your organisation. Ensure that staff are aware of the recommended actions in the manufacturer’s Field Safety Notice (FSN) you have ready access to a backup defibrillator until the software and hardware upgrades have been undertaken by Philips you have systems in place to arrange for the upgrades to be implemented.

Ask the manufacturer to add you to their distribution list for field safety notices (FSNs).

FSN Date: 31st October 2019

B Braun - Nutriflex Omega Plus and Nutriflex Omega Special - Product Recall 

B Braun is initiating a recall of certain batches of the above products as a precautionary measure. This is because ongoing product monitoring has identified that some bags may not comply with the required specification throughout the product shelf-life.

Class 2 Medicines Recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, PL 03551/0119, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, PL 03551/0118 and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31).

B Braun is initiating a recall of certain batches of the above products as a precautionary measure. This is because ongoing product monitoring has identified that some bags may not comply with the required specification throughout the product shelf-life.

Some unlicensed products have been manufactured by adding supplements to potentially affected Nutriflex Omega Plus and Nutriflex Omega Special bags, therefore certain batches of supplemented products are also being recalled.

FSN Date: 30th October 2019

CME (a BD company) - Syringe driver pumps - Field Safety Alert 

T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038).

Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

In April 2018 the manufacturer released an updated version of the T34 syringe driver pump, referred to as the 3rd edition.

The product identifier is 999-103EN

This was updated primarily to ensure compliance with version 3.1 of the medical electrical equipment and systems standard IEC 60601-1.

FSN Date: October 2019

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